Building a Real-World Evidence Center of Excellence: Lessons from the Frontlines
A Q&A with Margaret McDonald, Head of Apex Data Consulting, LLC, following a 17+ year career at Pfizer. Margaret McDonald is an accomplished analytic research scientist, healthcare executive and former hospital laboratory administrator with a Ph.D. in epidemiology, specializing in real-world data and analytics (RWD). She has expertise in global[…]
The Importance of Accounting for Time-Related Bias in Single-Arm Trials with Historical Controls (Part 2)
A Q&A with Samy Suissa, PhD In our previous blog post, we sat down with Dr. Samy Suissa, the co-founder and principal investigator of the Canadian Network for Observational Drug Effect Studies, to discuss the main themes from his recent journal article in Epidemiology. Namely, he argues that while single-arm trials with historical controls are[…]
The Importance of Accounting for Time-Related Bias in Single-Arm Trials with Historical Controls (Part 1)
A Q&A with Samy Suissa, PhD Randomized control trials (RCTs) are typically heralded as the gold standard in clinical trial design. However, regulatory agencies are increasingly recognizing the role of single-arm trials that leverage historical controls, especially within the rare disease space. Yet while these single-arm trials could have[…]
The Use of RWE in ICER Evaluations: What It Means for Life Sciences Companies
Real-world evidence (RWE) has been gaining acceptance at a rapid rate in many areas of the life sciences industry including R&D, epidemiology, outcomes research, and commercial groups. The COVID-19 pandemic and resulting research to find treatments and vaccines has accelerated the growth and adoption of RWE as well. The Institute for Clinical and[…]
Leveraging RWD in Observational Studies: Understanding the Implications of Time-Related Biases
A Q&A with Samy Suissa, PhD Dr. Samy Suissa is a Co-Founder and Principal Investigator of the Canadian Network for Observational Drug Effect Studies (CNODES). He is Director of the Centre for Clinical Epidemiology, Lady Davis Institute for Medical Research at the Jewish General Hospital and Professor, Departments of Epidemiology and Biostatistics[…]
Innovating RWE Organizations: Learning from the Past and Looking to the Future
A Q&A with Christopher Boone, PhD, FACHE, FHIMMS Christopher Boone, PhD, is Vice President, Global Head of Health Economics and Outcomes Research at AbbVie. He is also an adjunct assistant professor of health administration at the New York University's Robert F. Wagner Graduate School of Public Service, an active board member of several health[…]
Pharma Commercial Teams: Building an Analytics Culture as a Driver of Competitive Advantage
This is the second in a two-post series on driving transformation and competitive advantage through analytics for life sciences commercial teams.
Viewpoint: Life Sciences Should View Commercial Analytics Teams as a Revenue Generator
A Q&A with Vijay Raghavan, Associate Vice President, Market Analytics and Business Insights, AbbVie Vijay Raghavan is an Associate Vice President, Market Analytics and Business Insights at AbbVie. He was previously Head of Marketing Analytics for Allergan and was Program Committee Lead and Membership Chair for the Pharmaceutical Management Science[…]
How are Data Networks and International Collaboration Furthering Epidemiologic Research? A Q&A with Samy Suissa, PhD
Dr. Samy Suissa is a Co-Founder and Principal Investigator of the Canadian Network for Observational Drug Effect Studies (CNODES). He is Director of the Centre for Clinical Epidemiology, Lady Davis Institute for Medical Research at the Jewish General Hospital and Professor, Departments of Epidemiology and Biostatistics and of Medicine, McGill[…]
Interview with Dr. Mark Friedman on Covid-19 Complications and the Use of Real-World Data
Mark Friedman is VP of Medical Affairs for Panalgo. He is an internist with over 20 years of clinical and pharmacoeconomics consulting experience. He has management experience in the formulary and managed care implementation processes and also plays a major role in the design and implementation of clinically-oriented outcomes research studies,[…]